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Completed

NCT Number: NCT05916768

Management of Acute Bronchitis With Pelargonium Sidoides Extract

The aim of our study is to conduct a pragmatic RCT meeting all required standards to evaluate the effectiveness of Pelargonium sidoides extract, EPs® 7630, in the management of acute bronchitis with or without COVID-19 in PCP practices and walk-in clinics in French-speaking Switzerland. The RCT will be preceded by a pilot phase to ensure its feasibility.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Fribourg

Fribourg, Canton of Fribourg, 1700, Switzerland

About this study

The goal of this clinical trial is to evaluate the effectiveness of Pelargonium sidoides extract EPs® 7630, also known under the brand name Kaloba®, in the management of acute bronchitis.

The main questions it aims to answer are:

  • Is Pelargonium sidoides extract EPs® 7630 effective to reduce the severity and the duration of symptoms related to acute bronchitis ?
  • Does Pelargonium sidoides extract EPs® 7630 allow to reduce the prescription of antibiotics?

Participants will be randomize 1:1 either in the control group (usual care) or in the intervention group (Pelargonium sidoides extract EPs® 7630).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Adult patients (aged 18 and over) consulting for the first time, for the same episode, either for an acute cough (≤8 days) as the main symptom, suggestive of acute bronchitis, or for an illness (≤8 days) in which cough is not the main symptom but PCP believes that acute bronchitis is the most likely diagnosis.
  • Patients tested positive to COVID-19 who meet the above-mentioned criteria will be included too.

Exclusion criteria

  • Infection requiring antibiotic treatment (ex. cystic fibrosis)
  • Pneumonia
  • Known hypersensitivity to Pelargonium sidoides extract or excipients of the trial medication
  • Non-infectious causes (COPD, asthma, pulmonary embolism, heart failure, gastroesophageal reflux, allergy)
  • Lacking the faculty of discernment (for example: dementia, decompensated psychosis or severe depression)
  • Inability to fill out the diary (no ability to read and understand French)
  • Pregnancy or breastfeeding
  • Immunological deficiencies
  • Hospitalization
  • Severe hepatic disease
  • Patients who have already started a treatment with Pelargonium sidoides EPs® 7630 for this current episode (Kaloba®, Umckaloabo®)
  • Important risk of bleeding (severe thrombocytopenia and anticoagulant intake)
  • If the patient is taking a drug among these classes of drugs:

anticoagulants, immunosuppressants, chemotherapy or immunotherapy

Treatment and study plan

Pelargonium sidoides extract EPs® 7630

Other

Kaloba® solution, a standardized alcoholic extract obtained from the roots of Pelargonium sidoides (EPs® 7630).

Usual Care

Other

symptomatic treatments

Primary outcomes

  1. Effectiveness of Pelargonium sidoides extract EPs® 7630

    Time frame: 22 days

    Effectiveness will be determined by comparing the number of days needed to achieve a 50% reduction in the ABSS score after peak of symptoms in each group.

  2. Proportion of patients taking antibiotics

    Time frame: 22 days

    The co-medication, including antibiotics, will be collected by the investigator at day 4, 8 and 22. The results will be compared between the two arms.

Secondary outcomes

  1. Integration of a herbal medicinal product in conventional settings

    Time frame: 22 days

    Proportion of primary care physicians (PCPs) who agreed to participate in the study

Sponsors and collaborators

Lead sponsor

University of Fribourg

Other

Registry information

Official study title

Management of Acute Bronchitis in Switzerland With Pelargonium Sidoides Extract EPs®7630 Versus Usual Care - a Pragmatic, Open-label, Randomised Controlled Trial

Acronym: Phytobronch

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
Jun 23, 2023
Registry last updated
Jan 16, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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